FDA — authorised 16 March 2001
- Application: NDA021275
- Marketing authorisation holder: ABBVIE
- Local brand name: LUMIGAN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Lumigan in United States
FDA authorised Lumigan on 16 March 2001
Marketing authorisations
FDA — authorised 31 August 2010
- Application: NDA022184
- Marketing authorisation holder: ABBVIE
- Local brand name: LUMIGAN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 7 September 2011
- Application: NDA022369
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
FDA — authorised 1 December 2014
- Application: ANDA201894
- Marketing authorisation holder: APOTEX
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — TOPICAL
- Status: approved
FDA — authorised 20 February 2015
- Application: ANDA203991
- Marketing authorisation holder: LUPIN
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 May 2015
- Application: ANDA202565
- Marketing authorisation holder: SANDOZ
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 20 July 2015
- Application: ANDA090449
- Marketing authorisation holder: APOTEX
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 19 April 2016
- Application: ANDA202719
- Marketing authorisation holder: SANDOZ
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — TOPICAL
- Status: approved
FDA — authorised 9 October 2018
- Application: ANDA203051
- Marketing authorisation holder: HIKMA
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — TOPICAL
- Status: approved
FDA — authorised 8 November 2018
- Application: ANDA203299
- Marketing authorisation holder: HIKMA
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 March 2019
- Application: ANDA210126
- Marketing authorisation holder: GLAND
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 19 June 2019
- Application: ANDA207601
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 21 January 2020
- Application: ANDA210515
- Marketing authorisation holder: ALEMBIC
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — TOPICAL
- Status: approved
FDA — authorised 8 September 2020
- Application: ANDA202505
- Marketing authorisation holder: MICRO LABS
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 November 2020
- Application: NDA211911
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
FDA — authorised 6 October 2022
- Application: ANDA205537
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 17 March 2025
- Application: ANDA218196
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 9 September 2025
- Application: NDA217307
- Marketing authorisation holder: THEA PHARMA
- Local brand name: ZOLYMBUS
- Indication: GEL — OPHTHALMIC
- Status: approved
FDA — authorised 22 September 2025
- Application: ANDA217289
- Marketing authorisation holder: AMNEAL
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA203404
- Marketing authorisation holder: APOTEX INC
- Local brand name: BIMATOPROST
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA200487
- Marketing authorisation holder: SANDOZ
- Local brand name: BIMATOPROST
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA203056
- Marketing authorisation holder: SANDOZ INC
- Local brand name: BIMATOPROST
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA209797
- Marketing authorisation holder: GLAND PHARMA LTD
- Local brand name: BIMATOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
Lumigan in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Lumigan approved in United States?
Yes. FDA authorised it on 16 March 2001; FDA authorised it on 31 August 2010; FDA authorised it on 7 September 2011.
Who is the marketing authorisation holder for Lumigan in United States?
ABBVIE holds the US marketing authorisation.